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Abstract:

An electronic capsule (200) features a reservoir (204), and is configured
for placement within a reproductive organ, such as the uterus or cervix.
While located therein, the capsule dispenses (208), from the reservoir, a
substance, such as a reproductive hormone, semen, acidic buffer,
fertility drug or other drug, effectively administered from within the
organ. In some embodiments, the capsule has on-board sensors (238, 244)
and control circuitry in wireless communication with an external
processor functioning automatically or guided by a clinician or user, for
decisions and timing in administering the sub stance.

Claims:

1. An electronic capsule (200) comprising a reservoir (204), said capsule
configured for placement within a reproductive organ and, while located
within said organ, dispensing (S425), from said reservoir, a substance
effectively administered from within said organ.

2. The capsule of claim 1, further comprising a biosensor (244) for
measuring a level of a hormone, and further configured for said
dispensing based upon the measured level.

3. The capsule of claim 2, wherein said measuring is for one or more of
estradiol (310), luteinizing hormone (320) and follicle-stimulating
hormone (330).

4. The capsule of claim 1, so configured with said organ being a uterus
(104).

5. The capsule of claim 4, comprising a string (108) extending from said
capsule into a cervix.

6. The capsule of claim 1, so configured with said organ being a cervix
(116).

7. The capsule of claim 1, said dispensing being timed to a reproductive
cycle of a host (112) of said capsule.

8. The capsule of claim 1, comprising a pH sensor (238), and configured
such that said dispensing is responsive to output of said sensor.

9. The capsule of claim 1, so configured with said substance comprising a
fluid (395) carrying sperm.

10. The capsule of claim 9, configured for sensing, from an ambient
environment, a time (390) for the effective administering, and for said
dispensing of said substance at said time.

11. The capsule of claim 1, so configured with said substance comprising
progesterone (340).

12. The capsule of claim 1, so configured with said substance (158)
comprising a drug.

13. The capsule of claim 1, said capsule being further configured for
said dispensing (S425) for managing hormone levels for managing
endometriosis.

14. The capsule of claim 1, further dimensioned so that it is not
expelled by a body (112) comprising said organ.

15. The capsule of claim 14, so dimensioned without need for an outer
carrier (154) for preventing the expulsion.

16. The capsule of claim 1, a dispensing hole (208) of said reservoir
having a removable plug of oil.

17. The capsule of claim 1, comprising a motor (218) having a threaded
shaft supported on a transverse plate to reduce friction.

18. The capsule of claim 1, comprising a motor compartment with, for
pressure equalization, a hole (220) to an ambient environment of said
capsule.

19. A method comprising: inserting (S405) within a reproductive organ an
electronic capsule comprising a reservoir, said capsule configured for
placement within said organ; and while said capsule is located within
said organ, dispensing (S425), from said reservoir, a substance
effectively administered from within said organ.

20. The method of claim 19, wherein said dispensing comprises dispensing
an acidic buffer in response to a pH reading (244).

22. A computer software product for operating an electronic capsule
having a reservoir and located within a reproductive organ, said product
comprising a computer readable storage medium embodying a computer
program that includes instructions executable by a processor to perform a
plurality of acts, said plurality comprising the act of: while said
capsule is located within said organ (S405), dispensing, from said
reservoir, a substance effectively administered from within said organ.

23. An article of manufacture, comprising a machine-accessible medium
having instructions encoded thereon for enabling a processor to, while an
electronic capsule having a reservoir is located within a reproductive
organ, dispense (S425), from said reservoir, a substance effectively
administered from within said organ.

Description:

FIELD OF THE INVENTION

[0001] The present invention is directed to an electronic capsule for
placement in a body organ and, more particularly, for placement in a
reproductive organ and for dispensing a substance from within the organ.

BACKGROUND OF THE INVENTION

[0002] Infertility, or the inability of a couple to conceive a child,
affects about 7.3 million women and their partners in the U.S.--about 12%
of the reproductive-age population (Source: National Survey of Family
Growth, CDC 2002). Treatment approaches run a wide range from monitoring
body signs for ovulation to assisted reproductive technology such as
in-vitro fertilization. Even with various treatment approaches many
couples still have difficulty in bearing children. Unexplained
(idiopathic) infertility is a diagnosis made by exclusion in couples who
have not conceived and in whom standard investigations have not detected
any abnormality. It accounts for about 40% of female infertility and
8-28% of infertility in couples. Later stage treatments can be very
costly. A typical cycle of in-vitro fertilization costs about $12400 and
several cycles may be necessary.

[0003] U.S. Pat. No. 7,044,911 to Drinan et al. mentions a sensor-bearing
capsule for placement in the uterus or vagina. The sensor could detect a
change in temperature indicative of ovulation, thereby indicating a time
at which sexual intercourse is most likely to lead to fertilization. The
capsule would electronically send out an alert signal to the user.
Hormonal levels that indicate such a time could also be detected.

[0004] Although the alert is helpful, especially to those of degraded
fertility, for achieving pregnancy or achieving it quickly, many other
factors and contingencies are unmet or unresolved.

SUMMARY OF THE INVENTION

[0005] What is proposed herein is intended to address one or more of the
shortcomings of the prior art.

[0006] Infertility problems often do not have clear causes and a variety
of remedies are tried.

[0007] It is generally a goal to choose the least invasive, burdensome,
and costly solution that is effective.

[0008] One approach is monitoring and predicting the time of ovulation.
Alternatively, monitoring urine samples for hormone levels is more
accurate.

[0009] Automating these processes makes them more convenient for the
patient and less subject to error. Also, data can be easily and
accurately shared with one's doctor.

[0010] Often, however, there are problems with ovulation, with drugs being
therefore given to induce ovulation. Overstimulation that causes the
release of multiple eggs raises the probability of multiple pregnancies.
Multiple pregnancies are an unwanted outcome as they are strongly
associated with greater risk for development problems, pregnancy
difficulty to the mother, and higher costs.

[0011] Administration of the drugs must be timed to the patient's cycle,
which does require some monitoring and scheduling. Many of the hormonal
drugs are given by injection such as human chorionic gonadotropin (hCG),
human menopausal gonadotropin (hMG), and gonadotropin releasing hormone
(GnRH).

[0012] Injection is an inconvenient route of administration requiring
office visits or training for self administration.

[0013] Injections also have higher requirements for purity and sterility.

[0014] Most drugs used in treatments are systemically available. Systemic
drugs are generally more prone to side-effects as opposed to local or
topical delivery.

[0015] Drug stimulated ovulation is often practiced along with artificial
intra-uterine insemination (IUI). IUI requires an office visit and must
be conducted according to the time frame of the patient's ovulation
schedule.

[0016] Lastly if these approaches fail, in-vitro fertilization is
recommended. This procedure can be quite costly, invasive, and demanding
of the patient.

[0017] In one aspect of the present invention, an electronic capsule
features a reservoir, and is configured for placement within a
reproductive organ. While located therein, the capsule dispenses, from
the reservoir, a substance effectively administered from within the
organ.

[0018] In another aspect, the capsule has a biosensor for measuring the
level of a hormone, and is further configured for the dispensing based
upon the measured level.

[0019] In a sub-aspect, the measuring is for one or more of estradiol,
luteinizing hormone and follicle-stimulating hormone.

[0020] As a further aspect, the capsule is so configured with the organ
being a uterus.

[0021] In a sub-aspect of the above, the capsule has a string extending
from the capsule into a cervix.

[0022] In yet another aspect, the capsule is so configured with the organ
being a cervix.

[0023] In a different aspect, the dispensing is timed to the reproductive
cycle of the host of the capsule.

[0024] In some versions, the capsule includes a pH sensor, and is
configured such that the dispensing is responsive to output of the
sensor.

[0025] In a particular aspect, the capsule is so configured with the
substance comprising a fluid carrying sperm.

[0026] In a general aspect, the capsule is configured for sensing, from an
ambient environment, a time for the effective administering, and for the
dispensing of the substance at that time.

[0027] In one other aspect, the capsule is so configured with the
substance comprising progesterone.

[0028] In an alternative aspect, the capsule is so configured with the
substance comprising a drug.

[0029] In a yet further aspect, the capsule is further configured for the
dispensing for managing hormone levels for managing endometriosis.

[0030] In one particular aspect, the capsule is dimensioned so that it is
not expelled by a body comprising the organ.

[0031] In a particular sub-aspect, the capsule is so dimensioned without
need for an outer carrier for preventing the expulsion.

[0032] In an alternative version, a dispensing hole of the reservoir has a
removable plug of oil.

[0033] As a specific aspect, the capsule includes a motor having a
threaded shaft supported on a transverse plate to reduce friction.

[0034] In a further alternative aspect, a motor compartment of the capsule
has, for pressure equalization, a hole to an ambient environment of the
capsule.

[0035] A method, as proposed herein, includes, in yet an additional
aspect, inserting within a reproductive organ an electronic capsule
comprising a reservoir. The capsule is configured for placement within
the organ. The method further entails, while the capsule is located
within said organ, dispensing, from the reservoir, a substance
effectively administered from within the organ.

[0036] In a sub-aspect, the dispensing involves dispensing an acidic
buffer in response to a pH reading.

[0037] In an additional sub-aspect, the dispensing involves dispensing a
substance to induce ovulation.

[0038] In yet one further aspect, a computer software product for
operating an electronic capsule having a reservoir and located within a
reproductive organ includes a computer readable storage medium embodying
a computer program. The program includes instructions executable by a
processor to, while the capsule is located within said organ, dispense,
from the reservoir, a substance effectively administered from within the
organ.

[0039] In yet another embodiment, an article of manufacture includes a
machine-accessible medium having instructions encoded thereon for
enabling a processor to, while an electronic capsule having a reservoir
is located within a reproductive organ, dispense, from the reservoir, a
substance effectively administered from within the organ.

[0040] Details of the novel, electronic, intrauterine,
substance-administering capsule, or intelligent iPill, are set forth
further below, with the aid of the following drawings, which are not
drawn to scale.

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIGS. 1A, 1B are schematic diagrams exemplary of how the electronic
capsule is placed in a reproductive organ;

[0042]FIG. 2 is a schematic diagram of side and bottom views of the
electronic capsule;

[0043]FIG. 3 is a graph of hormone levels over time during a menstrual
cycle, showing, by example, when the dispensing mechanism may be
activated; and

[0044] FIGS. 4A, 4B are flow charts showing the status and activity of the
electronic capsule.

DETAILED DESCRIPTION OF EMBODIMENTS

[0045] FIG. 1A shows an electronic capsule 100 that has been placed within
a uterus 104.

[0046] A string 108 is optionally attached for removing the capsule 100
after a mammalian subject or patient 112, i.e., the host of the capsule,
becomes pregnant. The string extends down into the cervix 116 and may
extend further such as by two inches so as to be easily graspable with
the fingers. Also shown are the ovaries 120 where eggs are produced, and
the Fallopian tubes 124 in which fertilization occurs. An egg 128
released, or "ovulated," is shown later as a fertilized egg 132 in a
location typical for fertilization. A sperm 136 travels from the vagina
140 up past the cervical mucus 144 and into the uterus 104. The sperm 136
that succeeds in fertilizing the egg 132 travels through a Fallopian tube
124 to encounter and fertilize the egg. Typically, the capsule 100 is, as
indicated by the zigzags 148, electronically in communication with a
remotely located processor which carries out much of the computation and
has access to externally available information. The capsule 100 is sized
and shaped, i.e., dimensioned, to prevent expulsion by the body, as
through the cervix 116 and out through the vagina 140.

[0047] The capsule 150 in FIG. 1B has itself been placed in a larger
carrier 154. The capsule 150 is shown dispensing a substance 158, such as
a hormone, an acidic buffer, a drug or semen.

[0048]FIG. 2 depicts, by illustrative and non-limitative example, an
electronic capsule 200 in accordance with what is proposed herein. The
upper part of FIG. 2 portrays a side view of the capsule 200, and the
lower part portrays a bottom view, i.e., what would be visible if we were
to revolve the capsule 90° in the up direction.

[0049] The capsule consists of four distinct compartments within a housing
202 made of bio-compatible material.

[0050] A reservoir 204, for storing the substance 158 to be administered,
communicates to the direct, ambient environment 206 of the capsule 200
through a dispensing hole 208. This compartment 204 is separated from a
motor compartment 210 by a flexible, rolling sock seal 212. The material
of the seal 212 may be a polymer based laminate like a pharmaceutical
grade Polyethylene/Polychlorotrifluoroethylene (PE/PCTFE) flexible film.
To a stud or eyelet 214 protruding from the inner circumference of the
dispensing hole 208 the string 108 may be fastened.

[0051] The motor compartment 210 housing a stepper motor 218 communicates
to the direct, ambient environment 206 through a number of small sized
holes 220 in order to keep the pressure inside the capsule 200 exactly
equal to the pressure outside the capsule. The stepper motor 218 is
loosely fixed. In particular, when a piston 222 moves forward, the
threaded shaft 224 supports itself on a small, transverse, metal plate
226 so as to stay fixed in its axial direction. This is done to reduce
friction in case the piston 222 is loaded. The spherical shape of the
piston 222 along the rolling sock seal 212 widely distributes pressure
to, likewise, reduce friction. A threaded insert 227 of the piston 222
engages the threaded shaft 224 so that revolving of the shaft drives the
insert forward and therefore the piston which is fixed to the insert. A
start-up coil 228 for connecting a switch to the battery is included.

[0052] In an electronics compartment 230, all of the electronic components
232, including, among other components, batteries, control and data
storage, timing circuitry (not shown) and one or more antennas 233, are
mounted on a flex foil 234, which serves as a printed circuit board. The
flex foil 234 is made of a polymide substrate such as Kapton®. The
components 232 can be attached by soldering. The flex foil integration of
components 232, which advantageously reduces the number of components, is
described in more detail in commonly assigned International Patent
Publication Number WO 2008/062333A2, entitled "Ingestible Electronic
Capsule and In Vivo Drug Delivery or Diagnostic System," to Dijksman et
al., the entire disclosure of which is hereby incorporated herein by
reference.

[0053] After mounting of the components 232, the flex foil 234 is folded,
placed in the housing 202 and potted, in mouldable resin 235 for
instance, such that content of the ambient environment 206 cannot reach
the electronics 232. A measuring surface 236 of an ion-selective field
effect transistor (ISFET) 238 directly communicates with the environment
206. The ISFET is usable, for example, to measure pH levels. The
communication is by means of an orifice 240 in the housing 202. Another
orifice 242 exists for a biosensor 244 for measuring hormone levels. A
channel 246 connects the two orifices 240, 242. Motion of a
biorecognition element (not shown) of the biosensor 244 and the presence
of the channel 246 afford flow of fluid from the ambient environment 206
past the element and past the ISFET measuring surface 236. The
biorecognition element can be moved electrically or electromagnetically.
A suitable biosensor is disclosed in commonly assigned U.S. Patent
Publication 2008/0311679, entitled "Biosensor Device," to Den Toonder et
al., the entire disclosure of which is hereby incorporated herein by
reference.

[0054] A reference electrode compartment 248 includes a reference
electrode 250 for the ISFET 238. The reference electrode 250 consists of
a short silver wire covered with silver chloride, and is placed in a gel
252 with 4.5 mol/litre KCl. A fit window 254 seals the gel 252 inside and
affords the means by which the reference electrode 250 communicates
ionically with the outside of the capsule 200.

[0055] For a long shelf life, the electronic control circuitry is
completely decoupled from the battery, or other power source, to prevent
a small leakage current from expending the power in the battery. A
wake-up circuit may be used to activate the coupling. The circuit is
powered from outside by inductive radiation that is received by the
start-up coil 228.

[0056] The housing 202 includes a first part 256 and a second part 258.
The first part 256 is secured to the second part 258. The rolling sock
seal 212 is clamped between the first part 256 and the second part 258,
thereby securely sealing off the motor 212 from the substance 158 to be
dispensed. As seen in FIG. 2, the first and second parts 256, 258 are
joined in a protrusion/recess configuration. In this way the sealing
length of the rolling sock seal 212 is enlarged, which increases the
sealing strength of the seal and hence the reliability of the device 200.
The sealing properties can be further enhanced by using biocompatible
adhesives for the adhesion of the seal 212 in between the protrusion and
joining recess. Alternatively, ultrasonic frictional heating or laser
welding may be applied.

[0057] The housing 202 may be fabricated from a biologically safe
polymeric material such as, for example, polytetrafluoroethylene,
polypropylene, polyethylene, acrylics and the like. The housing 220 can
be manufactured from materials used to fabricate implantable devices,
including pacemaker leads and cardiac prosthesis devices, such as
artificial hearts, heart valves, intra-aortic balloons, and ventricular
assist devices. Optionally, a proper coating is applied to the surface of
the device to ensure biocompatibility.

[0058] In operation, the piston 222 moves forward, pressing against the
flexible, rolling sock seal 212. This causes displacement that forces the
substance 158 through the dispensing hole 208. The amount dispensed can
be precisely controlled by the stepping action of the stepper motor 218.
For simplicity of fabrication and operation the dispensing hole 208 is
simply an open window. That is, no mechanical valve is used to separate
the medication compartment from the outside environment. To prevent
unwanted release of drug, a removable plug, e.g., oil droplet, can be
applied to the open window. The shape and size of the window can be
chosen to reduce undesired diffusion to a satisfactory level.

[0059] Use of the piston 222 to create pressure is safer than using gas.
Also, the piston 222 need not conform to tight tolerances in order to
hermetically seal the reservoir 204; instead, the rolling sock seal 212
serves that function.

[0060] According to the instant proposal, measurement, monitoring, and
analysis are used to determine the time point in the reproductive cycle
of the patient 112. Drug delivery is used to enhance the cycle and
conditions for successful conception. Timing of the drug delivery is
controlled by a program internal to the implanted device 200 along with
data and analysis communicated between the device and outside equipment.

[0061] The capsule 200 is in wireless contact with a receiver system
outside the body 112, as by a radiofrequency (RF) link. The receiver
system can record data reported by the capsule 200 such as measurements
from the sensors 238, 244. Other sensors, such as a temperature sensor,
may be on-board the capsule 200. Likewise, only one or fewer than all of
such sensors may be on-board. These measurements can give information as
to the state of the patient 112. Analysis of the data by computer program
or observer can be used as intelligent input to take an action such as
delivery of the drug 158 from the same capsule 200.

[0062] Monitoring of hormone levels, for example hCG level, other chemical
markers, or examination for example by ultrasound may be used to
determine when successful embryo implantation occurs and thus when the
capsule 200 should be removed. Further considering the device is intended
to reside for a fixed period of one to several months, the material of
the carrier may be such that it erodes or becomes less rigid over time.
This may aid in the removal of the device with a minimum of mechanical
trauma to the cervix 116 and uterus 104 during removal.

[0063] One function of the device is to monitor in-situ the condition of
the patient 112 to determine the time of ovulation. The capsule 200 can
contain a temperature sensor for this purpose. The sensor periodically
records basal body temperature. The device additionally contains a
wireless communication means. For example an RF wireless chip is
contained on the device. The device transmits data from the measurements
to an external unit. The external unit stores and/or relays measurements
to a computing device such as a personal computer. The external unit or
personal computer uses the temperature data along with time stamps to
chart body temperature much in the way a manual basal body temperature
(BBT) chart is used. In this case the measurement, charting, and analysis
are automatic, requiring no action from the patient. To provide
additional information, the system may be designed to record manual input
from the patient to mark the exact time she rises from bed.

[0064] While temperature and the BBT chart are good indicators for
ovulation it is retrospective and subject to interfering influences. A
better indicator is to monitor hormonal levels. Thus the capsule 200 may
include the biochemical sensor or biosensor 244 to measure hormonal
levels. Candidate analytes include estradiol, luteinizing hormone, and
follicle stimulating hormone.

[0065]FIG. 3 indicates hormone levels over time during a menstrual cycle,
showing, by example, when the dispensing mechanism may be activated. The
hormones for which levels are shown are estradiol 310, luteinizing
hormone 320, follicle stimulating hormone 330, and progesterone 340. The
time periods prior to ovulation 350 are the follicular phase 360 and
menstruation 370, and the time period after is the luteal phase 380. As
seen from FIG. 3, estradiol 310 is a particularly effective predictor for
the commencement of ovulation, although there is a noticeable rise in the
other hormones 320, 330, 340.

[0066] Levels of estradiol 310 and luteinizing hormone 320 are detectable
in the uterine environment, as by means of the biosensor 244 discussed
hereinabove. Again measurements are reported to an external unit,
recorded, and analyzed. Data analysis at the external unit or computing
device will indicate to the patient 112 and/or doctor when the optimal
time for conception is. This may be used to plan natural or artificial
insemination, which preferably occurs at the commencement 390 of
ovulation.

[0067] Alternatively or in addition, the capsule 200 may be configured
with the pH sensor 238. The pH of the cervix and uterine environment
changes with menstrual cycle. An acidic pH is harmful to sperm 136. pH
tends to rise near the time of ovulation 350. Thus a monitoring of pH can
give information as to whether conditions are favorable for conception.
The information can be used for cycle prediction, diagnosing sub-optimal
conditions and/or indicating whether corrective actions are desirable
such as the release of a substance to raise and buffer the pH.

[0068] The substance 158 dispensed from the reservoir 204 may be a drug to
stimulate or assist ovulation, such as hormonal, hormonal analogs, or
large molecule drugs with local action. Local administration in the
uterus is more effective as it is at or near the site of action. Further,
hormones or large molecules are typically not orally bioavailable. By
releasing the drug from the capsule 200 the need for administration by
injection is eliminated. Moreover, since the drug is topically active,
the amount of drug reaching systemic circulation shall be much reduced
along with drug side-effects. The delivery of the drug is, in some
embodiments, appropriately timed to the patient's reproductive cycle. For
example, luteinizing hormone 320 is needed at the time of ovulation 350
to induce release of a mature egg 128 from the follicle. Timing and
amount of drug delivery is under control of the device electronics 232
that takes action using input from on-board data as well as external data
and analysis. External data including timing triggers are communicated
wirelessly from the external unit to the capsule 200. The dose and
duration of drug delivery can also be adapted to the specifics of the
individual 112. As it may be an assist to deficiencies in natural
hormonal production, the data from actual body levels can be used to
determine the desired delivery dose and duration. This can for example be
adapted over the course of delivery which can be over several days.

[0069] Alternatively or in addition to promoting proper ovulation, the
device may deliver one or more drugs that promote conditions for
successful implantation of the fertilized egg 132 to the endometrium,
i.e., the cells that line the uterus 104. It is not uncommon for a
successful fertilization to end with an unsuccessful implantation. The
empty follicle produces progesterone 340 to prepare the endometrium. A
defect in this process or proper levels reduces the chance of successful
conception. In this case the capsule 200 will deliver progesterone 340.
The system is ideally disposed to this mode as progesterone 340 is
topically active and is delivered to the uterus 104. Local delivery by
the capsule 200 solves problems with poor bioavailability of progesterone
340 by oral delivery or inconvenience of delivery by vaginal enema.
Additionally progesterone delivery is preferable to administration of
synthetic analogs such as progestin which may carry additional
side-effects.

[0070] In yet another embodiment, the substance 158 delivered may be a
fluid carrying sperm 136, e.g., semen (or seminal fluid containing
sperm). This is a kind of artificial intra-uterine insemination. The
advantage of delivery by the implanted capsule 200 is that the
insemination can happen at the optimal time without the need for an
additional office visit necessarily scheduled around the time of
ovulation. Here the system monitoring and prediction feature is used to
calculate the optimal time for insemination and a trigger signal is
delivered wirelessly to the capsule 200. The capsule 200 then releases
the semen 395 bearing active sperm 136 at the right time 390.

[0071] The system may also find utility in areas other than fertility,
i.e., in other gynecology applications, especially where the combination
of measurement, monitoring, and drug delivery brings benefits. An example
is in treatment for endometriosis. Endometriosis occurs when tissue from
the uterine lining attaches to other organs in the body (such as the
cervix, vagina, intestines, etc.) and begins to grow. Irritation, pain,
and infertility can result. Common treatments include birth control
hormones to halt ovulation and the associated growing, shedding, and
bleeding of endometrial tissue that makes endometriosis painful. Rather
than halting the menstrual cycle altogether, an intelligent, electronic
capsule based therapy can be used to deliver medication to manage
hormonal levels in order to reduce the amount of tissue swelling that
leads to painful endometriosis. Estrogen levels, for example, may be
lowered to treat or prevent endometriosis. Obtaining a more natural
balance is expected to have fewer side effects that come with
conventional drug therapies such as progestin or Danozol®. Side
effects include irregular uterine bleeding, weight gain, water retention,
breast tenderness, headaches, nausea, and mood changes, particularly
depression.

[0072] An alternative to placement in the uterus 104 or cervix 116 is to
embed or implant the capsule 200. For example implant the capsule 200
subcutaneously. In this embodiment the capsule 200 would be designed to
be smaller to ease implantation. Further, depending on a trade off
between desired functions and size or difficulties with implants, the
capsule 200 may reduce, or be configured with reduced, functions, for
example to be strictly a monitor device and system.

[0073] Lastly, the capsule 200 may serve as general drug delivery system.
In certain applications drugs can be more effectively and conveniently
absorbed through the vaginal or uterine tissues. Application is not
necessarily restricted to fertility, infertility or gynecology. For
example large molecule drugs, proteins, peptides, or other drugs that are
poorly absorbed, degraded, or otherwise poorly bioavailable via the
intestinal tract may be more effectively delivered through other organs
such as the lung, mouth, or eye. Included are the vaginal or uterine
routes for women. This area has a thick network of blood vessels that
enhances the utility of this route for drug delivery. The capsule 200 can
reside in the cervix 116 or uterus 104 and deliver a drug that is
absorbed through these organs. This is preferred for example to delivery
by injection or infusion. Additionally if the target organs are at or
near the uterus 104 then effective therapy may be possible at reduced
systemic drug levels, leading to fewer side-effects. Local administration
also avoids first pass metabolism as the drug may be directly perfused
into the nearby tissues. Among therapy areas where uterine or vaginal
delivery may be beneficial are, hormone replacement therapy, urinary
incontinence, endometriosis, vaginal microbicides, vaginal vaccination,
and pain relief.

[0075] In a dispensing process 400, first the capsule 200 is placed in the
reproductive organ (step S405). An external signal wakes up the control
circuitry (step S410). These two steps may be performed in reverse order.
The capsule 200 then senses the ambient environment 206 and takes
readings (step S415). The readings and/or information received from an
external source are used by the capsule 200 and/or an external processor
to determine one or more dispensing times (step S420). Dispensing of the
substance 158 in the reservoir 204 occurs (step S425). If the capsule 200
is still present in the organ (step S430), processing returns to step
S415; otherwise, processing ends.

[0076] In a monitoring process 450, hormone levels, such as for human
chorionic gonadotropin (hCG), are monitored to detect pregnancy (step
S455). If the subject 112 is not pregnant (step S460), and the capsule
200 is not expired (step S465), processing returns to step S455. If, on
the other hand, the subject 112 is pregnant (step S460) or the capsule
200 is expired (step S465), the capsule 200 is removed from the organ in
which it has been placed (step S470). The monitoring process 450 may
initially be dormant, and commenced some time before capsule life expiry
or after insemination naturally or by means of semen being dispensed from
the reservoir 204.

[0077] An electronic capsule features a reservoir, and is configured for
placement within a reproductive organ, such as the uterus or cervix.
While located therein, the capsule dispenses, from the reservoir, a
substance, such as a reproductive hormone, semen, acidic buffer,
fertility drug or other drug, effectively administered from within the
organ. In some embodiments, the capsule has on-board sensors, and control
circuitry in wireless communication with an external processor
functioning automatically or guided by a clinician or user, for decisions
and timing in administering the substance.

[0078] The capsule 200 is applied in health-related treatments. In
particular, uterine residence, monitoring, and adaptable control make it
well-suited for fertility, infertility, or gynecology applications. More
generally, the system may be used as a drug delivery system which is
preferable to delivery by injection or infusion.

[0079] It should be noted that the above-mentioned embodiments illustrate
rather than limit the invention, and that those skilled in the art will
be able to design many alternative embodiments without departing from the
scope of the appended claims. For example, the electronic capsule 200 may
be provided with an image sensor and the ability to reorient, or
otherwise move, itself to detect or measure the local existence of
endometriosis. In the claims, any reference signs placed between
parentheses shall not be construed as limiting the claim. Use of the verb
"to comprise" and its conjugations does not exclude the presence of
elements or steps other than those stated in a claim. The article "a" or
"an" preceding an element does not exclude the presence of a plurality of
such elements. The invention may be implemented by means of hardware
comprising several distinct elements, and by means of a suitably
programmed computer having a computer readable medium. The mere fact that
certain measures are recited in mutually different dependent claims does
not indicate that a combination of these measures cannot be used to
advantage.

Patent applications by Jeff Shimizu, Briarcliff Manor, NY US

Patent applications in class Implanted dynamic device or system

Patent applications in all subclasses Implanted dynamic device or system